Mitral valve inversion prostheses

ABSTRACT

The present disclosure includes a method that includes inserting an implant proximate a mitral valve, the implant comprising a tubular body and a plurality of piercing members, the tubular body comprising an upper diameter and a lower diameter. The method also includes engaging tissue proximate the mitral valve by the plurality of piercing members and transitioning the tubular body from a first structural configuration to a second structural configuration by application of an expansive force to the tubular body proximate the upper diameter, the first structural configuration having the upper diameter smaller than the lower diameter and the second structural configuration having the upper diameter larger than the lower diameter. The present disclosure also includes associated systems and implants.

PRIORITY INFORMATION

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37C.F.R. § 1.57.

For example, this application is a divisional application of U.S. patentapplication Ser. No. 14/427,909, filed Mar. 12, 2015, which is a U.S.National Phase Application of PCT International Application NumberPCT/US2013/059751, filed on Sep. 13, 2013, designating the United Statesof America and published in the English language, which is anInternational Application of and claims the benefit of priority to U.S.Provisional Patent Application Ser. No. 61/700,989, filed Sep. 14, 2012.The disclosures of the above-referenced applications are herebyexpressly incorporated by reference in their entireties for all purposesand form a part of this specification.

TECHNICAL FIELD OF THE DISCLOSURE

This disclosure relates generally to cardiac treatment devices andtechniques, and in particular, to methods and devices for repair ofmitral valve defects such as mitral valve regurgitation.

BACKGROUND

The mitral valve is one of four heart valves that direct blood throughthe two sides of the heart. The mitral valve itself consists of twoleaflets, an anterior leaflet and a posterior leaflet, each of which arepassive in that the leaflets open and close in response to pressureplaced on the leaflets by the pumping of the heart.

Among the problems that can develop or occur with respect to the mitralvalve is mitral valve regurgitation (MR), in which the mitral valveleaflets become unable to close properly, thus causing leakage of themitral valve. Severe mitral regurgitation is a serious problem that, ifleft untreated, can adversely affect cardiac function and thuscompromise a patient's quality of life and life span.

Currently, mitral regurgitation is diagnosed by many indicators, and themechanism of mitral regurgitation can be accurately visualized bytrans-esophageal echocardiography or fluoroscopy with dye injection. Themost prevalent and widely accepted current technique to correct mitralregurgitation is to repair the mitral valve via open-heart surgery whilea patient's heart is stopped and the patient is on cardiopulmonarybypass, a highly invasive procedure that has inherent risks.

SUMMARY

In one embodiment, the present disclosure includes a method comprisinginserting an implant proximate a mitral valve, the implant comprising atubular body and a plurality of piercing members, the tubular bodycomprising an upper diameter and a lower diameter. The method alsoincludes engaging tissue proximate the mitral valve by the plurality ofpiercing members and transitioning the tubular body from a firststructural configuration to a second structural configuration byapplication of an expansive force to the tubular body proximate theupper diameter, the first structural configuration having the upperdiameter smaller than the lower diameter and the second structuralconfiguration having the upper diameter larger than the lower diameter.

In an alternative embodiment, the present disclosure includes an implantcomprising a tubular body comprising an upper diameter and a lowerdiameter, the tubular body having a first structural configuration inwhich the upper diameter is smaller than the lower diameter and a secondstructural configuration in which the upper diameter is larger than thelower diameter, the tubular body configured to transition from the firststructural configuration to the second structural configuration byapplication of an expansive force to the tubular body proximate theupper diameter. The implant also comprises a plurality of piercingmembers connected to the tubular body and proximate the lower diameterto engage tissue proximate a mitral valve.

In an additional embodiment, the present disclosure includes a systemcomprising a guide wire, a sheath over the guide wire, and an implantfor delivery to a body by traveling through the sheath and along theguide wire. The implant comprises a tubular body comprising an upperdiameter and a lower diameter, the tubular body having a firststructural configuration in which the upper diameter is smaller than thelower diameter and a second structural configuration in which the upperdiameter is larger than the lower diameter, the tubular body configuredto transition from the first structural configuration to the secondstructural configuration by application of an expansive force to thetubular body proximate the upper diameter. The implant also comprises aplurality of barbs connected to the tubular body and proximate the lowerdiameter to penetrate tissue proximate a mitral valve.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present disclosure and itsfeatures and advantages, reference is now made to the followingdescription, taken in conjunction with the accompanying drawings, inwhich:

FIGS. 1A-1F illustrate an example embodiment of an implant m accordancewith the present disclosure;

FIGS. 2A-2D illustrate an alternative example embodiment of an implantin accordance with the present disclosure;

FIGS. 3A-3B illustrate a further alternative example embodiment of animplant in accordance with the present disclosure;

FIGS. 4A-4B illustrate an additional example embodiment of an implant inaccordance with the present disclosure;

FIG. 5 illustrates examples of delivery routes of an implant, inaccordance with the present disclosure;

FIG. 6 illustrates an example embodiment of the present disclosureutilizing vibrations, in accordance with the present disclosure;

FIG. 7 illustrates an alternative example embodiment of the presentdisclosure utilizing vibrations, in accordance with the presentdisclosure; and

FIG. 8 illustrates an additional example embodiment of the presentdisclosure utilizing vibrations, in accordance with the presentdisclosure.

DETAILED DESCRIPTION

The present disclosure relates to an implant including a tubular bodyand piercing members for reshaping a mitral valve suffering from mitralregurgitation. The implant may include two or more structuralconfigurations. In a first structural configuration, an upper diameter(away from the mitral valve) may be smaller than a lower diameter(proximate the mitral valve). In this first structural configuration,the piercing members of the implant may engage the tissue proximate themitral valve, for example, the mitral valve annulus. The implant maythen be transitioned from the first structural configuration to a secondstructural configuration in which the size of the upper diameter islarger than the lower diameter. This may be facilitated by an expansiveforce causing the upper diameter to expand, in tum causing the lowerdiameter to contract. As the lower diameter contracts, the penetratingmembers engaged with the tissue proximate the mitral valve may cause themitral valve to also contract to a smaller diameter. This may allow thevalve leaflets to close properly, addressing mitral regurgitation.

FIGS. 1A-F illustrate one embodiment of an implant. For example, asshown in FIG. 1A, in some embodiments, repair of a mitral valve may beachieved by a catheter system and catheterization procedure, wherein acatheter may be configured for percutaneous access to the mitral valvethrough the left ventricle.

Access may be granted to the left ventricle through the apex of theheart where an incision may be made to insert a dilator and sheath 150for access of a repair catheter 140. Sheath 150 may measure about sixFrench to about thirty French and a closure device may be used inconjunction with the entry of this access catheter 140.

In one embodiment of the present disclosure, catheter 140 may include anextendable guide wire assembly 160, which may guide the system intoposition. Guide wire 160 may measure between 0.010 inches and 0.038inches in diameter, and may be 0.035 inches in diameter. Catheter 140 orsheath 150 when accessed through the apex of the heart may measure abouttwenty to thirty centimeters in length.

As shown in FIG. 1 B, once access has been achieved, a delivery systemmay be introduced through sheath 150 along guide wire 160 with implant110 for reducing the diameter of the mitral valve annulus. Catheter 140may deliver implant 110 to resize the mitral valve to reduce the mitralvalve cross sectional area or move the posterior leaflet back intoposition limiting or reducing mitral valve regurgitation.

Implant 110 may include a tubular body with portions of the tube removedsimilar to a stent structure where a portion of the material may beremoved via laser cutting or other means to selectively cut portions ofthe tube away forming a radially-expandable tubular body. Implant 110may be introduced in a collapsed structural configuration. Thiscollapsed structural configuration may allow implant 110 to fit withinsheath 150 to allow for a percutaneous procedure rather than anopen-heart procedure. As shown in FIG. 1 B, once implant 110 arrives inthe left atrium, implant 110 may be expanded to a larger firststructural configuration to engage tissue proximate the mitral valve,for example, the mitral valve annulus. In one embodiment, implant 110may have a tubular shape with a free diameter of about twenty five toabout thirty five millimeters in diameter, a height of about ten toabout thirty millimeters, and a wall thickness of between about 0.005inches and about 0.040 inches. Implant 110 may be constructed of ametallic material such as stainless steel, MP35N alloy, Nitinol or otherimplantable material.

In some embodiments, implant 110 may be tapered such that one end may belarger in diameter than the other end, appearing generally frustoconicalin shape. The diameters of the ends may be approximately twenty fivemillimeters on the smaller end and approximately thirty five millimeterson the larger end. Implant 110 may also be non-circular where a portionof the implant may be elliptical or include a radial portion that isflat. This flat portion may be oriented toward the aortic valve and thecircular portion may be positioned toward the posterior leaflet. Tofacilitate discussion of implant 110, an upper portion and lower portionmay be described. The lower portion may refer to the end of implant 110proximate mitral valve 170 while the upper portion may refer to the endof implant 110 free in the left atrium.

The implant 110 is shown in the figures to include a plurality of strutsarranged such that adjacent pairs of struts are joined to form upper andlower apices. Implant 110 may include piercing members 115 proximate thelower portion of implant 110, for example coupled to each lower apex,proximate mitral valve 170, for example, the mitral valve annulus.Piercing members 115 may include barbs or hooks similar to fish hookbarbs or other similar feature to resist withdrawal from tissue oncepierced. Piercing members 115 may include a single barb or hook, or aplurality of barbs or hooks per piercing member 115. Piercing member 115may be immediately exposed or covered for delivery. They may number fromone to fifty and may have a length of about four to twenty millimetersin length. They may have the same wall thickness as a wall of thetubular body of implant 110 or may differ with an increased or decreasedthickness or taper in either direction to allow for mechanicalintegrity.

Piercing members 115 of implant 110 may be integral or attached toimplant 110 as a secondary component glued, welded, or attached as anancillary part. Piercing members 115 may also be laser cut into implant110, and therefore attached to implant 110. The barbs or hooks may befatigue resistant from fracture or separation from piercing members 115.For example, the barbs or hooks may have additional strength or wallthickness at the connection to piercing members 115. The barbs or hooksmay also be attached with a hinged attachment allowing motion relativeto the heart, but not longitudinally where the barbs or hooks mayseparate from piercing member 115.

The barbs or hooks of piercing member 115 may be active or passivemeaning that the barbs or hooks may be activated with heat to bend orexpose or mechanically formed through an external force to bend orexpose. For example, each barb or hook may be sheathed inside a tube andremoval of this tube may allow the barb or hook to be activated by, forexample, body heat or some other activation factor, such that the barbor hook is exposed so as to engage the surrounding tissue. In a passiveconfiguration, the barbs or hooks may be static in nature and eitheralways exposed or exposed as soon as a covering is removed. The barbs orhooks may be hidden until deployment limiting the exposure duringdelivery and positioning and only exposed once positioning is finalized.The exposure may be completed as individual barbs or as multiples ofbarbs. In some embodiments, the covering is thus only a temporarycovering.

As shown in FIG. 1B, in some embodiments, implant 110 may be positionedat the annulus of mitral valve 170 where the mitral valve hinge meetsthe left ventricle and the left atrium meets mitral valve 170.Positioning implant 110 at this location may be facilitated using alocation ring 120. For example, location ring 120 may be positionedwithin the left ventricle, under mitral valve 170. A catheter to deliverlocation ring 120 may be placed in the left ventricle via the sameaccess point through sheath 150. In some embodiments, location ring 120may comprise a metallic ring or coiled section, which may be viewed viafluoroscopy or echo guidance to confirm the location of location ring120. This may allow confirmation of a positive location for implant 110to be located with respect to the mitral valve annulus. In addition tothe use of a location ring, other methods for determining a desiredlocation to attach implant 110 may could include echo guidance, CT,fluoroscopy or MRI other imaging techniques to highlight the mitralvalve hinge.

As shown in FIG. 1C, while in a first expanded structural configuration,and once a proper position has been achieved, implant 110 may have adownward force “A” applied to cause piercing members 115 to engage withand/or pierce the mitral valve annulus. This force may be applied by thedelivery system itself, or may be applied by a secondary catheter thatmay be introduced for engaging piercing members 115 with the tissueproximate mitral valve 170.

As shown in FIG. 1D, in some embodiments, location ring 120 may also actas an anchor for implant 110. In such an embodiment, implant 110 abovemitral valve 170 (i.e. in the left atrium side of mitral valve 170) mayattach to location ring 120 below mitral valve 170 (i.e. in the leftventricle side of mitral valve 170). For example, the hooks or barbs ofpiercing members 115 may engage with location ring 120. This may beaccomplished by a through suture, a barbed means, wrapping or clippinglocation ring 120 to implant 110. Magnetic forces may also hold locationring 120 and implant 110 together either temporarily or permanently.Alternatively, the hooks or barbs may also be attached to some otherseparate implant below mitral valve 170 in the left ventricle. This maybe a wire, ring, or tee anchor to secure implant 110 to via wires,threads or mechanical means to attach through the tissue median. Forconvenience, this implant below mitral valve 170 may be referred to aslocation ring 120, even if not used in locating implant 110 proximatemitral valve 170.

In some embodiments, the shape of location ring 120 may be a circularcross section measuring about 0.010 inches to about 0.090 inches indiameter and may encircle the mitral annulus. The shape may also benon-circular, oval, biased to one axis or multi-axis to accommodate themulti-plane shape of mitral valve 170, which is more saddle shaped. Itmay also have a variable stiffness in different sections to accommodatetighter bends in the placement of location ring 120. Location ring 120and or a delivery catheter may also be steerable to navigate the areaunder mitral valve 170 for ease of placement. Utilizing push pull wiresto compress or load portions of the catheter or location ring 120 topredictably bend and orient the catheter or location ring 120 may allowa user to access difficult anatomical features en route to and aroundmitral valve 170.

As shown in FIG. 1E, once piercing members 115 have engaged the tissueproximate mitral valve 170, for example, the mitral valve annulus, anexpansive force “B” may be applied to the upper portion of implant 110.By applying expansive force “B” to implant 110, a reactive reducingforce “C” may also be produced at the lower portion of implant 110. Asthe diameter of the lower portion is decreased from reactive reducingforce “C,” the diameter of mitral valve 170 is also reduced due to theattachment of implant 110 to the tissue around mitral valve 170. Forexample, once a sufficient reducing force “C” has been generated toreshape mitral valve 170 to a desired size, implant 110 may be left in afinal position in which the size change of mitral valve 170 may bemaintained. This may be a second structural configuration.

As shown in FIG. 1F, in some embodiments, piercing members 115 mayengage the tissue proximate mitral valve 170 but not engage locationring 120. In such an embodiment, the barbs or hooks of piercing members115 may bind, engage with, and/or resist withdrawal from tissueproximate mitral valve 170 in a manner sufficient to keep implant 110attached to the tissue proximate mitral valve 170. Additionally, thebinding, engaging, and/or resisting withdrawal may be sufficient todecrease the surface area of mitral valve 170 as expansive force “B” andreactive reducing force “C” are applied. In such an embodiment, locationring 120 may or may not be used to facilitate placing implant 110 at apositive location proximate mitral valve 170. A positive location forimplant 110 may be one in which implant 110 is able to engage tissueproximate mitral valve 170 without impairing the function of mitralvalve 170 and further implant 110 may be used to decrease the surfacearea of mitral valve 170 as expansive force “B” and reactive reducingforce “C” are applied.

FIGS. 2A-2D illustrate an example of implant 110 in accordance with thepresent disclosure. As shown in FIG. 2A, implant 110 may be made of ametal and cut to form a mesh, a cage, or series of repeating units toallow variations in diameter. For example, implant 110 may include atubular body of repeating squares, diamonds, hexagons, or any othershape allowing a variation in diameter of implant 110. In firststructural configuration as shown in FIG. 2A, implant 110 may have thelarger diameter portion initially oriented toward mitral valve 170 (thelower portion with lower diameter 220) and the smaller diameter may beoriented in the left atrium (the upper portion with upper diameter 210).The upper portion may be in free space in the left atrium and have asmaller diameter ready to be expanded in this first structuralconfiguration.

The construction of implant 110 may include a tapered laser cut tubeexpanded to a predetermined diameter with wall thickness approximately0.005 inches to approximately 0.050 inches and a strut thickness ofapproximately 0.010 inches to approximately 0.070 inches and an expandeddiameter of approximately 1.00 inch. If the implant is tapered, thelarge diameter may measure about thirty five millimeters in diameter andthe smaller diameter may measure about twenty five millimeters indiameter. In the first structural configuration, the lower portion (i.e.the larger diameter section) may have penetrating members 115 to engagethe mitral annulus and hold implant 110 in position during annulsreduction and remain as a permanent implant.

As shown in FIG. 2B, downward force “A” may be applied to implant 110.In some embodiments, piercing members 115A-H may be driven to engage thetissue one at a time. For example, a linear force may drive the hooks orbarbs of piercing member 115A into the tissue by pushing at the top ofimplant 110 above piercing member 115A, thus transmitting a forcethrough to the piercing member 115A, driving it into the tissue. Thedelivery system or catheter applying the force may then be rotated andactuated again to engage another piercing member 115, for exampleadjacent piercing member 115B. Once piercing member 115B has beenengaged with the tissue, this may be repeated until all piercing members115 have been engaged with the tissue. Alternatively, in someembodiments, force “A” may be sufficient to engage multiple piercingmembers 115 at once, rather than engaging only a single piercing member115 at a time. In some embodiments, all of piercing members 115 may beengaged at once.

As shown in FIG. 2C, implant 110 may be in a first structuralconfiguration in which upper diameter 210 may be smaller than lowerdiameter 220. An expansive force “B” may be applied to the upper portionof implant 110. As the expansive force “B” is applied such that theupper diameter 210 is increased, the lower diameter 220 may be decreaseddue to a reactive reductive force “C” which is generated. A wall of thetubular body of implant 110 may act as a beam in deflection where theupper portion of implant 110, when deflected (e.g. expanded), may causethe lower portion of implant 110 to bend (e.g. contract). This mayfacilitate the transition from this first structural configuration to asecond structural configuration. The lower diameter 220 may be proximatepiercing members 115, which are engaged with the mitral valve annulus.Thus, as lower diameter 220 becomes smaller, the diameter of mitralvalve 170 becomes smaller. The expansive force “B” may be applied viaballoon dilation, mechanical expansion or other means to increase upperdiameter 210, thus reducing lower diameter 220. This may effectivelyinvert implant 110's dimensions about axis 200, which may be referred toas an axis of inversion or axis of reflection. In some embodiments, thediameter of implant 110 at axis 200 may remain approximately uniform ina first structural configuration, transitioning between structuralconfigurations, and a second structural configuration. As shown in FIG.2D, the application of expansive force “B” and thus reactive reducingforce “C” may result in implant 110 with upper diameter 210 having alarger length and lower diameter 220 having a shorter length. This mayin tum reduce barb-engaged mitral valve 170 to a smaller annuluscross-sectional area, lessening the mitral regurgitation. The structuralconfiguration shown in FIG. 2B may be the second structuralconfiguration of implant 110 in which mitral valve 170 has been reducedin annulus cross-sectional area. Additionally, this second structuralconfiguration may be a final structural configuration that may maintainthe size change of mitral valve 170.

As shown in FIGS. 3A and 3B, an alternative method for applying anexpansive force to implant 310 may be the deployment of a ring 320within implant 310. FIG. 3A illustrates implant 310 in a firststructural configuration and FIG. 3B illustrates implant 310 in a secondstructural configuration. In some embodiments, a fixed ring 320 may beutilized. Fixed ring 320 may be moved vertically to expand the upperportion to increase upper diameter 330, thus causing the lower portionto reduce lower diameter 340 along with the engaged tissue and mitralvalve. For example, upward force “D” may be applied to ring 320.However, because of the frustoconical shape of implant 310, the upwardforce “D” may be translated to an expansive lateral force causing anincrease in upper diameter 330. Ring 320 may lock into implant 310 by aninterference fit or a mechanical stop built in ring 320 or implant 310,and may maintain implant 310 in the second structural configuration.

Alternatively, an expandable ring 320 may be used rather than a fixedring. Expandable ring 320 may be positioned within implant 310 and maybe delivered and expanded by a catheter using hydraulic or mechanicalforce to expand ring 320. Ring 320 may be introduced into implant 310'sinner diameter where ring 320 may be tilted to allow for manipulation orpositioning. Alternatively, ring 320 may be placed at a defined verticalposition in implant 310 and ring 320 may be expanded with mechanical orhydraulic force or an extension of the radial dimension. Ring 320 mayalso serve as a locking mechanism for implant 310 once the secondstructural configuration or the final position has been reached. Theexpansion and/or locking of ring 320 may be reversible in nature, thusundoing the expansion of the upper portion. Ring 320 may lock intoimplant 310 by an interference fit or a mechanical stop built in ring320 or implant 310.

FIGS. 4A and 4B illustrate an additional embodiment of an implant 410for reshaping mitral valve 170. FIG. 4A illustrates implant 410 in afirst structural configuration and FIG. 4B illustrates implant 410 in asecond structural configuration. As shown in FIG. 4A, in someembodiments, implant 410 may include one or more support beams 420 (forexample, support beams 420A and 420B). Support beams 420 may facilitatethe transition of expansive force “B” to the reductive force “C.” Forexample, support beam 420 may operate as a beam in deflection about axis450. Thus, as expansive force “B” is applied to the upper portion ofimplant 410, beams 420A and 420B may act as levers with axis 450 as thefulcrum or point of rotation, causing reductive force “C” to reducelower diameter 440. As expansive force “B” is applied to increase upperdiameter 430 and decrease lower diameter 440, implant 410 may transitionfrom a first structural configuration shown in FIG. 4A to a secondstructural configuration shown in FIG. 4B. As described above, this mayreduce the cross-sectional area of mitral valve 170.

Support beams 420A and 420B may be integrally formed with implant 410,for example, as a thicker portion of a wall of the tubular body ofimplant 410, or a specific alignment of repeating units or elements ofthe structure of the wall of the tubular body. Alternatively, supportbeams 420A and 420B may be an additional support component added toimplant 410. For example, they may be glued, welded, or otherwisepermanently affixed to implant 410.

As shown in FIG. 5, in addition to access to mitral valve 170 throughthe apex of the heart as shown by 510, access to mitral valve 170 mayalso be gained via the femoral artery through the aortic valve as shownby 530, or through the venous system and then via trans-septal puncturedirectly into the left atrium as shown by 520. When accessed via thefemoral artery or trans-septally, a delivery catheter may measure aboutninety to one hundred and fifty centimeters in length. The end of thecatheter may be deflectable via deflection wires creating tension ofbias to allow adjustments due to anatomical variations.

As shown in FIG. 6, vibration may be applied directly to penetratingmembers 115 to facilitate the barbs or hooks and/or penetrating members115 penetrating the tissue. Low frequency vibration, ultrasonic, orRadio Frequency energy may allow a lower insertion force compared to thebarb or hook's and/or penetrating members' normal penetration force.Coupling this energy source to implant 110 may allow transmission ofsmall vibrations 620 to the tip of each barb or hook and/or penetratingmember 115. Alternatively, each barb or hook and/or penetrating member115 may have its own independent energy source allowing a variablepattern of frequency or energy around implant 110. Direct tissue contactof the energy element or a coupling to implant 110 may be used but theremay be a decrease in efficiency by coupling vibration 620 thereto. Thefrequency of vibration 620 may be about ten to one hundred Hz (cyclesper second) or may be about twenty Hz.

As shown in FIGS. 7 and 8, to aid in the engagement of the penetratingmembers 115, additional energy may be added to vibrate the tissuesurrounding or below mitral valve 170. For example, as shown in FIG. 7,vibration pads 710A and 710B may deliver vibration 620 to thesurrounding tissue near the barbs or hooks of penetrating members 115.Pads 710A and 710B may be used to vibrate the tissue near the barbinsertion site. Pads 710A and 710B may be completely separate fromimplant 110 or may be connected to the same delivery system. A separatecontrol for linear and radial motion of pads 710A and 710B may beprovided to control the location to provide precise delivery ofvibration 620.

As shown in FIG. 8, vibration pads 810A and 810B may also be locatedbelow mitral valve 170. This may still provide vibration 620 tofacilitate the engagement of barbs or hooks of penetrating members 115with tissue proximate mitral valve 170. As with the embodiment of FIG.7, vibration pads 810A and 810B may be completely separate from implant110 or may be connected to the same delivery system. A separate controlfor linear and radial motion of pads 810A and 810B may be provided tocontrol the location to provide precise delivery of vibration 620.

Radio frequency (RF) is a rate of oscillation in the range of aboutthree kHz to three hundred GHz, which corresponds to the frequency ofradio waves, and the alternating currents, which carry radio signals. RFusually refers to electrical rather than mechanical oscillations. Belowis a chart of common nomenclature for different frequency ranges. Therange utilized for barb penetration may be somewhere between ELF and HFas the goal is small vibration and not heating of the tissue. Possibleuser range selection would allow for different tissue types anddensities.

TABLE 1 Ab- Frequency Wavelength Designation breviation 3-30 HZ 10⁵-10⁴km Extremely low ELF frequency 30-300 Hz 10⁴-10³ km Super low frequencySLF 300-3000 Hz 10³-100 km Ultra low frequency ULF 3-30 kHz 100-10 kmVery low frequency VLF 3-300 kHz 10-1 km Low frequency LF 300 kHz-3 MHz1 km-100 m Medium frequency MF 3-30 MHz 100-10 m High frequency HF30-300 MHz 10-1 m Very high frequency VHF 300 MHz-3 GHz 1 m-10 cm Ultrahigh frequency UHF 3-30 GHz 10-1 cm Super high SHF frequency 30-300 GHz1 cm-1 mm Extremely high EHF frequency 300 GHZ-3000 GHz 1 mm -= 0.1 mmTremendously THF high frequency

This disclosure encompasses all changes, substitutions, variations,alterations, and modifications to the example embodiments herein that aperson having ordinary skill in the art would comprehend. Similarly,where appropriate, the appended claims encompass all changes,substitutions, variations, alterations, and modifications to the exampleembodiments herein that a person having ordinary skill in the art wouldcomprehend. Moreover, reference in the appended claims to an apparatusor system or a component of an apparatus or system being adapted to,arranged to, capable of, configured to, enabled to, operable to, oroperative to perform a particular function encompasses that apparatus,system, component, whether or not it or that particular function isactivated, turned on, or unlocked, as long as that apparatus, system, orcomponent is so adapted, arranged, capable, configured, enabled,operable, or operative. For example, various embodiments may performall, some, or none of the steps described above. Various embodiments mayalso perform the functions described in various orders.

Although the present disclosure has been described above in connectionwith several embodiments; changes, substitutions, variations,alterations, transformations, and modifications may be suggested to oneskilled in the art, and it is intended that the present disclosureencompass such changes, substitutions, variations, alterations,transformations, and modifications as fall within the spirit and scopeof the appended claims.

What is claimed is:
 1. An implant for reshaping a mitral valve annulus, the implant comprising: a tubular body in the form of a mesh of repeating shapes comprising a plurality of struts, with adjacent pairs of struts joined to form a plurality of upper apices and lower apices, the tubular body comprising an upper portion with an upper diameter and a lower portion with a lower diameter, the upper portion configured to be free in the left atrium and the lower portion configured to engage tissue around a mitral valve, the tubular body having a first structural configuration in which the upper diameter is smaller than the lower diameter and a second structural configuration in which the upper diameter is larger than the lower diameter; and a plurality of piercing members coupled to the lower apices.
 2. The implant of claim 1, further comprising a vibration pad for applying vibration to at least one of the plurality of piercing members.
 3. The implant of claim 1, further comprising a fixed ring positioned within the tubular body, the fixed ring comprising a diameter larger than the upper diameter in the first structural configuration such that when the fixed ring is moved proximate the upper diameter, the implant transitions from the first structural configuration to the second structural configuration.
 4. The implant of claim 1, further comprising an expandable ring proximate the upper diameter, the expandable ring configured to increase the upper diameter of the implant when the expandable ring is expanded.
 5. The implant of claim 1, further comprising a temporary covering for at least one of the plurality of piercing members.
 6. The implant of claim 1, wherein each distal apex includes at least two heat activated piercing members.
 7. The implant of claim 1, wherein a wall of the tubular body acts as a beam in deflection when transitioning from the first structural configuration to the second structural configuration.
 8. The implant of claim 1, wherein the plurality of piercing members are configured to extend radially outward proximate the lower portion to engage tissue proximate the mitral valve annulus.
 9. The implant of claim 1, wherein the implant has the second configuration at least when the implant is engaged to the tissue proximate the mitral valve.
 10. The implant of claim 1, wherein the plurality of piercing members are secondary components attached to the implant.
 11. The implant of claim 1, wherein the repeating shapes of the mesh overlap one another.
 12. A system comprising: a guide wire; a sheath for sliding over the guide wire; an implant for delivery to a body by traveling through the sheath and along the guide wire, the implant comprising: a tubular body in the form of a mesh of repeating shapes comprising a plurality of struts, with adjacent pairs of struts joined to form a plurality of upper apices and lower apices, the tubular body comprising an upper portion with an upper diameter and a lower portion with a lower diameter, the upper portion configured to be free in the left atrium and the lower portion configured to engage tissue around a mitral valve, the tubular body having a first structural configuration in which the upper diameter is smaller than the lower diameter and a second structural configuration in which the upper diameter is larger than the lower diameter; and a plurality of piercing members connected to the lower apices of the tubular body.
 13. The system of claim 12, further comprising a location ring configured to be located on a side of the mitral valve opposite the implant.
 14. The system of claim 13, wherein the implant is configured to couple with the location ring.
 15. The system of claim 12, wherein the plurality of piercing members are coupled to the implant with a hinged attachment.
 16. The system of claim 12, wherein each distal apex includes at least two heat activated piercing members.
 17. The system of claim 12, further comprising a catheter configured to be introduced through the sheath for engaging the plurality of piercing members to cause the plurality of piercing members to penetrate the tissue proximate the mitral valve.
 18. The system of claim 12, wherein the repeating shapes of the mesh overlap one another.
 19. An implant for reshaping a mitral valve annulus, the implant comprising: a tubular body in the form of a mesh of repeating shapes comprising a plurality of struts, with adjacent pairs of struts joined to form a plurality of upper apices and lower apices, the tubular body having an upper portion with an upper diameter and a lower portion with a lower diameter, the upper portion configured to be free in the left atrium and the lower portion configured to engage tissue around a the mitral valve annulus, the tubular body having an anchored configuration in which the upper diameter is larger than the lower diameter; and a plurality of piercing members connected to the lower apices of the tubular body proximate the lower diameter and configured to extend radially outward in the anchored configuration to engage tissue proximate the mitral valve.
 20. The implant of claim 19, wherein the plurality of piercing members are coupled to the implant with a hinged attachment. 